Carrier system for delivery of an end of an elongated member to the upper gastrointestinal tract

ABSTRACT

A two stage device for delivering an elongated member to the upper gastrointestinal tract consisting of an outer gelatin pharmaceutical capsule which dissolves in the stomach, an inner open ended capsule contained in said outer capsule and being nonsoluble in the gastro-intestinal tract and having walls inwardly deflectable under peristaltic action of the upper gastro-intestinal tract in the absence of the outer capsule and carrying a weight and a portion of the elongated member. The device being used to deliver cord or tubing at least as far as the duodenum where the carrier separates from the elongated member and passes harmlessly out with the stool. The elongated member as a tube carries medicines, other liquids or gas to the duodenum, and as a yarn is retrieved and examined for diagnosing infection, parasites and other disorders.

United States Patent Beal [54] CARRIER SYSTEM FOR DELIVERY OF AN END OFAN ELONGATED MEMBER TO THE UPPER GASTROINTESTINAL TRACT [72] Inventor:Charles B. Bea], 1875 Oakdell Dr.,

Menlo, Calif. 94025 221 Filed: Oct. 2, 1970 [21] App1.No.: 77,574

Related US. Application Data [63] Continuation-in-part of Ser. No.771,573, Oct.

29, 1968, abandoned.

[52] US. Cl ..128/2 W, 128/260, 128/271 [51] Int. Cl. ..A6lb 10/00 [58]Field of Search ..128/2 R, 2 W, 2 A, 2 B, 2 F,

128/2 G, 2 M, 2 P, 260, 264, 213, 172, 271,

[56] References Cited UNITED STATES PATENTS 813,829 2/1906 Robarts..128/271 1,880,964 10/1932 Kunsztler .l ..128/2 3 f 2,701,559 2/1955Cooper ..128/2 2,773,502 12/1956 Kaslow et a1. ..128/260 3,074,396 1]1963 Maclean ..128/2 3,097,636 7/1963 Haynes, Jr. et a1. ..128/23,155,091 11/1964 Nissenbaum et a1 ..128/2 3,421,499 1/1969 Bray et a1..............128/2 [15] 0 3,683,890 [451 Aug.15 ,1972

-3,4s3,ss9 12/1969 Pittmanm. ..128/2 FOREIGN PATENTS OR APPLICATIONS281,869 2/1915 Germany ..128/1.3 194,270 3/1967 .U.S.S.R..... ..128/2VOTHER PUBLICATIONS Gladstone, S. A., Amer. Journ. of ClinicalPathology, Vol. 19, No. 9, Sept. 1949, pp. 891- 894.

Primary Examiner-Ky1e L. Howell Attorney-Milmore & Cypher ABSTRACT A twostage device for delivering an elongated member to the uppergastrointestinal tract consisting of an outer gelatin pharmaceuticalcapsule which dissolves in the stomach, an inner open ended capsulecontained in said outer capsule and'being nonsoluble in thegastro-intestinal tract and having walls inwardly deflectable underperistaltic action of the upper gastro-intestinal tract in the absenceof the outer capsule and carrying a weight and a portion of theelongated member. The device being used to deliver cord or tubing atleast as far as the duodenum where the carrier separates from theelongated member and passes harmlessly out with the stool. The elongatedmember .as a tube carries medicines, other liquids or gas to theduodenum, and as a yarn is retrieved and examined for diagnosinginfection, parasites and other disorders.

8 Claims, 9 Drawing Figures PATENTEDAUB 15 I972 3, 683, 890 snwmrzINVENTOR. Charles B. B 0! PATENTEDAUB 15 I972 SHEET 2 [IF 2 INVENTOR.Charles B. B

CARRIER SYSTEM FOR DELIVERY OF AN END OF AN ELONGATED MEMBER TO THEUPPER GASTROINTESTINAL TRACT The present application is a continuationin part of my prior co-pending U.S. Pat. application Ser. No. 771,573filed Oct. 29, 1968 now abandoned.

BACKGROUND OF THE INVENTION Existing methods of sampling the contents ofthe upper gastrointestinal tract consist in swallowing a weight andline, inch by inch. Many patients have great difficulty in carrying outthis test because the movement of the line against the oropharynx causesthem to gag on the string and. nausea often results.

Other methods consist of passing a small tube to the small intestinethrough the nose or mouth into the stomach and then into the duodenum byinserting a wire or mandrel through the entire length of the tube. Thismethod is difficult, extremely uncomfortable for the patient, timeconsuming for doctors, immobilizes the patient for several hours, andfrequently requires xray verification to determine whether the tube haspassed into the duodenum.

Other methods of determining the contents of the upper gastrointestinaltract such as the presence of parasites is by examination of the fecalcontents. This method often fails to reveal their presence, particularlythose parasites living in the duodenum or bile ducts. Again, this methodis time consuming for the laboratory technician.

SUMMARY The gist of this invention is the use of a two stage capsulewhich encapsulates a line or tube. The capsule is swallowed and the lineor tube pays out an opening. As the two stage capsule travels to theduodenum, only the capsule is moving in relation to thetract and thesensation of gagging is reduced or completely eliminated.

The outer capsule is a gelatin pharmaceutical capsule which is easilyswallowed and moves freely through the alimentary canal to the stomachwhere it dissolves and drops away from the inner capsule. The weightedinner capsule does not dissolve but instead the upper thin wallscollapse forming a miniature bag which is of sufficient size with a lowspecific gravity so that it moves from the stomach, through the pylorusand into the duodenum. The walls of the inner capsule are collapsed bythe peristaltic action present in the tract and lightly grasp the lineor tube as it passes out of the capsule, thus preventing too rapid payout and consequent knotting.

Accordingly, an object of the present invention is to provide a systemfor delivering the end of a string or tube to the upper intestinal tractwhich is simple, inexpensive, presents minimal discomfort for thepatient, can be administered with little expenditure of time fortechnical personnel and which will nearly always pass into the duodenumspontaneously, avoiding the need of x-ray verification.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a cross sectional view ofthe device constructed in accordance with the present invention.

FIG. 2 is a schematic view of the device shown in use as it passesthrough the stomach.

FIG. 3 is a cross sectional view of the device taken substantially alongline 3-3 of FIG. 2 showing the condition of the device as it would occurimmediately after entry in the stomach.

FIG. 4 is a schematic view of the device shown in use immediately afterreaching the target area in the duodenum.

FIG. 5 is a cross sectional view of the device taken substantially alongthe line 5--5 showing the condition of the device as it would occur uponreaching the sampling area.

FIG. 6 is a cross sectional view of an alternate form of the device fordelivering a tube to the duodenum.

FIG. 7 is a cross sectional view of a portion of the alternate deviceshown in FIG. 6 as it would appear passing through the stomach andpylorus.

FIG. 8 is a cross sectional view of a portion of the al temate deviceshown in FIG. 6 as it would appear in the duodenum and just prior torelease of the inner capsule from the tube.

vention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention consistsbriefly of an outer number 00 gelatin pharmaceutical capsule ldissolvable in the stomach from the normal presence of moisture andwarmth and having an opening 2 in one end. The capsule may be formedwith or without a separate cap 3. If provided with a cap, it may or maynot have an inner lining insoluble in the upper gastrointestinal tract.Such lining would have no opening therein and should be attached to thecapsule 4 described below. An inner open ended capsule 4 non soluble inthe upper gastrointestinal tract is nested within the first capsulewhich has side walls 5 which deflect inwardly and form av miniature bagwith a constructed opening 7 as shown in FIG. 5 upon being subject tothe normal peristaltic action in the upper gastrointestinal tract forlightly grasping an elongated flexible element 8 contained by the innercapsule. for play ing out of the capsule openings. The inner capsule isweighted such as with a small amount of lead 9. The weight serves thedual purpose of structurally maintaining a portion of the walls so that:a certain volume and specific gravity will be maintained so that theinner capsule will have sufficient bulk to be readily advanced by normalperistaltic action through the pylorus and into the small intestine.

The two stage capsule may act as a carrier of a small tube 13' to theupper gastrointestinal tract which can be used directly for transmissionof pressure for operation of microinstruments carried with or in thecapsule to the area of sampling. The tubing may be used to injectmedicines or liquid radiopaque material to the duodenum for x-rays. Airmay be injected to cause foam to take out folds so as to x-ray theduodenum.

In its simplest form, the elongated element merely consists of a cord oryarn 13 which will detach from the other parts of the capsule uponreaching the prescribed terminus so that the weighted portion will notbe drawn up the length of the alimentary canal when the cord is removedfrom the mouth.

In still another form of the invention, the elongated element mayinclude radiopaque markers 11 attached to the element so that theposition and course of the line in the gastrointestinal tract may bedetermined by x-ray. The markers may be made of fine metal wire such asstainless steel or aluminum, coiled around the line or they may bebarium loaded rubber or latex members affixed to the cord. The markersmay also be formed by merely coating the string with barium loadedrubber.

In still another form of the invention the elongated element consists ofa distal end 12 consisting of a short length of leader thread such as a1.5 cm No. 70 weight thread, which in turn is attached to the leadweight as shown in FIG. 5, or thread 12 attached to the inside top wallof the inner capsule as shown in FIG. 8. Packed in the capsule is alength of yarn 13 such as a three-ply white nylon yarn of about 80 cm.length. The length should be shorter for children. The distal end of theyarn is attached to the leader by a simple overhand knot 14. The leaderthread is placed in the knot in a manner to avoid sharp angulation ofthe thread. The knot grasps the thread tightly enough so that thecapsule will pull the yarn behind it as it passes from the stomach intothe duodenum, but loosely enough so that a vertical pull on the yarnwill cause it to separate from the leader thread. The knot is adjustedso that a force of 30, plus or minus, grams of vertical steady tractionwill cause it to separate from the thread, when tested in the dry state.The knot will hold the weight or the inner capsule when suspended in thedry state. The free ends of the thread and yarn at the knot are cutshort, leaving only a 2-3 mm length on either side of the knotpreventing the free ends from becoming entangled in use.

It has been found that thread is less irritating to the throat than theyarn. Further, the thread may be coated with a substance such assilicone rubber to make it still more acceptable. Accordingly, theproximal end of the yarn is securely attached to a cm. length or so ofthread 16 such as a size No. 24 thread, in a knot 17. A 2 3 cm. loop 18is made on the free end of the thread. The loop protrudes through theopening in the capsule. After administration of the capsule, the threadis taped to the face and left in place.

The outer capsule is a hard shell gelatin pharmaceutical capsule such asa size No. 00 with a hole of approximately 4 mm in diameter in the top.The inner capsule may be constructed in several ways. It may be formedas a separate capsule of rubber, silicone rubber or a plastic such asthat sold under the trademark Mylar, or it may be merely a thin coatingof a flexible, non-toxic plastic such as polyvinylchloride or Neoprenecoated on the interior surface of the outer capsule. This coating mayhave a dry weight of about 100-150 mgm. Other types of coatings could beused such as the film produced from the polyester of ethylene glycol andterephthalic acid known by the trademark Mylar, or silicone rubber. Oneform of silicone rubber which may be used is Silastic, Medical AdhesiveSilicone Type A, as sold by Dow Coming.

The Silastic is mixed with toluene and coated on the inside of the outergelatin capsule. The toluene evaporates and the Silastic cures leaving awall thickness of between 0.0l0 to 0.020 inch.

The weighted inner capsule may be provided with a hemispheric shapedlead weight 9, as shown in FIG. 5,

weighing approximately 1 gram.

The method of using the present invention is as fol lows. The loop ofthe thread is held in one hand and the patient swallows the test capsulewith approximately one-half cup of water. The loop of thread is thenattached to the face or, if desired, to a tooth. The capsule descendsinto the stomach, the thread and yarn playing out as required. Thepurpose of the gelatin capsule is to provide the appropriate rigidity,shape, texture and solubility for public acceptability and ease inswallowing. Note, for instance, that the outer capsule wall in FIG. 3 isdecreased in section to indicate the solubility of the outer capsule.

The packing of the line inside the capsule allows it to be deliveredinto the gastrointestinal tract without any motion of the yarn inrespect to the oropharynx thereby avoiding the nausea producingsensation of a line or tube moving across the back of the throat. Onlypersons with a very sensitive gag reflex are bothered by the presence ofthe thread in the throat.

In the stomach, the gelatin of the outer capsule melts completelyleaving the inner flexible, non-absorbable, weighted capsule. The wallsof the inner capsule are sufficiently thin that they collapse inwardlyunder normal peristaltic pressure and the inner cylindrical capsule nowassumes the shape of a miniature bag substantially closed at its openend. The purpose of the inner plastic capsule is fivefold:

1. To house the line, allowing it to play out as needed.

2. To deflect inwardly at its open end, thereby offering some resistanceto the playing out of the yarn to prevent too rapid play out andpossible knotting.

3. To encase and contain the lead weight.

4. To add bulk to the weight, providing a bolus of sufficient size to bereadily advanced by peristaltic action.

5. To diminish the specific gravity of that of the lead weight itself,thereby increasing the tendency of the capsule to be swept into theduodenum with the liquid contents of the stomach.

The sensation of swallowing the device is similar to that of swallowingan ordinary pharmaceutical capsule of similar size. Though passage ofthe capsule from stomach to duodenum may require l-3 hours or more, verylittle discomfort is experienced by the patient. Nor is he restricted inany way except from eating solid food during the course of the test.After a period of 3-4 hours the yarn is removed simply by pulling it outof the mouth. The process requires about 4 seconds and is accompanied byonly momentary gagging in most subjects. The inner capsule with itsweight continues down the intestines and passes out unnoticed with thestool.

The part of the yarn that had been in the intestine generally is coloredyellow or green from bile staining. The mucous material clinging to theyarn may be scraped off and examined as desired. Usually five to sixdrops are obtained.

positive diagnosis of various parasites in the upper intestines such asthe finding of hookworm eggs. Other conditions which may be diagnosed byobtaining a sample of duodenal contents are: (1) parasitic infections ofthe duodenum or bile ducts, (2) bacterial infections of the smallintestine; (3) typhoid carrier state; (4) gall bladder stones in certaininstances; (5) deficiency of the digestive enzymes of the pancreas; (6)bleeding in the esophagus, stomach or duodenum. (7) cancer in the uppergastrointestinal tract, gall bladder or pancreas. The latter abnormalitymay be detected by examining microscopically the desquamated cellscollected with the mucous.

An alternate form of the device, shown in FIGS. 6, 7 and 8 is identicalin nearly all respects to the form of the invention shown in theprevious figures. The main difference is the substitution of a tube forthe yarn. Accordingly, only the differences in construction will be setforth to avoid repetition.

Referring to FIG. 6, the two stage delivery device consists briefly ofan outer gelatin capsule 1' having an opening 2' in one end. The capsulemay be formed with or without a separate cap 3'. An inner open endedcapsule 4', non-soluble in the upper gastrointestinal tract, is nestedwithin the first capsule and has side walls 5 which deflect inwardly andform a miniature bag with a constricted opening 7' as shown in FIG. 7upon being subject to the normal peristaltic action in the uppergastrointestinal tract for lightly grasping an elongated flexibleelement 8' contained by the inner capsule for playing out of the capsuleopenings. The inner capsule is weighted, as with a small amount of lead9'.

As stated previously, the capsules carry a small tube 13' made ofsilicone rubber such as the Silastic tubing sold by Dow Corning. Thistubing folds flat so that a length of approximately 1 meter can beeasily stored within the capsule. The tubing need not be coiled withinthe capsule but may be merely stuffed therein in somewhat accordionstyle to avoidknotting as the tube plays out.

As in the previous form of the invention, the weighted inner capsule isattached to the elongated member, or tube in this instance, in such amanner so that it separates from the tube when the tube is manuallypulled back. As shown in FIG. 8, the tube is attached to a short lengthof soft yarn 10, made of nylon or cotton the yarn is attached to thetubing by silicone glue or other means. The yarn contains an overhandknot 14' through which a short length of thread 12 is placed. The knotholds the thread as previously described, and releases under anapproximately 30 gram steady pull.

Preferably, the thread is attached to the upper end of the inner capsuleby a silicone glue in the approximate location shown in FIG. 8 denotedby the arrow A. Thus, in the event the knot does not release by pullingback the proximal end, the distal attached end of the thread will tearaway from the inner capsule, preventing the likelihood of discomfortureto the patient in withdrawing the tube with the weight connectedthereto.

The elongated tube may be used alone to inject medicines directly intothe duodenum as set forth above, or it may be used with a length of yarnto perform all of the tests set forth in relation to the form of theinvention set forth in FIGS. 1-5. This alternate form is shown in FIG.9. This form of the invention is in all respects identical to the twoprevious forms except I ous forms with the thread 12" separating fromthe knot 14" when the capsule (not shown) reaches the duodenum.

The operation of the alternate forms of the invention shown in FIGS. 6-9are as follows: The patient swallows the capsule while he or a technicalmedical person holds the proximal end of the tube. The gelatin capsulemoves downwardly; playing out the tube through its opening. By the timethe outer capsule reaches the stomach, it is partially dissolved, andthe dissolution is completed therein. Having completed its function tocarry the tube to the stomach, the outer gelatin capsule drops away fromthe inner capsule, permitting the light inner capsule walls to collapseas shown in FIG. 7. A quantity of tubing remains in the inner capsulewhile the device is still in the stomach as shown in FIG. 7. The upperwalls, collapsed by the peristaltic action normally present, grasp thetube ligh'tlyand prevent all of the remaining tubing from coming out ofthe capsule at once. The inner collapsed capsule, now in the form of aminiature bag finds its way through the pylorus to the duodenum. Whenthe bag reaches the full length of the tube and the tube is manuallypulled back, the small thread 12' or 12" pulls through the knot 14' or14" respectively and the inner bag and weight finds its way out in thestool. The normal peristaltic action and the anatomical construction ofthe upper gastrointestinal tract resist the pull back of the bulky bag.The lead weight insures the requisite bulk so that peristaltic ac-' tionwill act upon the bag. As stated above, if the knot does not release thethread 12 or 12", the end of the thread is lightly attached to the innercapsule so that it will tear away under the manually pulling back. Atthis point, the end of the tube is in the duodenum. Placing a quantityof air or medicine through the tube will ex pand it from its collapsedstate and permit the air or medicine to be conveyed directly to theduodenum.

After the procedures are completed, the tube may be recovered bywithdrawing it. If the tube is accidentally swallowed, it will make itsway out with the stool, and without discomforture to the patient.

In the form of the invention shown in FIG. 9, the tube and the yarn arerecovered and mucous absorbed by the yarn may be examined.

I claim:

1. A carrier system for delivery of an end of an elongated member to theupper gastrointestinal tract comprising:

a. an outer gelatin pharmaceutical capsule dissolvable in the uppergastrointestinal tract from the normal presence of moisture and warmthand having an opening in one end thereof;

b. an inner capsule enclosed by said outer capsule having an open endbstantially coaxially aligned with the opening of said outer capsule,and being non-soluble in said gastrointestinal tract and completelycontained within said outer capsule,

and having inwardly deflectable walls collapsible in the absence of saidouter capsule by peristaltic action present in the uppergastrointestinal tract for lightly grasping the element of paragraph (d)below between the edges of the walls:

0. a weight, non-dissolvable in the upper gastrointestinal tract,carried in the bottom portion of said inner capsule and providingstructural support to the walls of the inner capsule at said bottomportion so that said inner capsule is of sufficient bulk to be readilyadvanced by peristaltic action through the stomach;

d. an elongated flexible element releasably connected to saidinnercapsule and having a first position substantially contained within saidinner and outer capsules for playing out of said capsule openings to asecond distended position within said gastrointestinal tract, said innercapsule containing said elongated element which is adapted for remainingafter said outer capsule has dissolved and until said inner capsule hasmoved to the duodenum; and

e. said elongated element and said inner capsule adapted for remainingconnected during delivery of the distal end of said element to theduodenum, and said inner capsule adapted for being releasable from saidelement in the duodenum upon manually withdrawing said elongatedelement. I

2. A device as described in claim 1 wherein said elongated element is aflexible line of yarn.

3. A device as described in claim 1 including radiopaque markersattached to the elongated element at selected intervals so that theposition and course of the line in the gastrointestinal tract may bedetermined by x-ray.

4. A device as described in claim 1 comprising:

a. a first thread connected to said inner capsule;

b. the distal end of said elongated element being formed with a knot;and

c. the free end of said first thread being connected to I said elongatedelement by said knot and releasable therefrom in the duodenum by manualwithdrawal of said elongated element.

5. A device as described in claim 1 comprising:

a. said inner capsule is made from silicone rubber;

and

b. a second thread connected to the proximal end of said elongatedmember, having a length adapted to extend from the mouth through thethroat.

6. A device as described in claim 1 wherein said elongated element is aflexible collapsible tube.

7. A device as described in claim 6 comprising:

a. a length of yarn connected to the distal end of said tube and havinga knot formed in its free end.

b. a connector thread attachedto the upper inner wall of said innercapsule and attached to said length of yarn by said knot; and

c. said knot adapted for holding said connector thread until said innercapsule reaches the duodenum.

8. A device as described in claim 1 comprising:

a. said elongated element consisting of a yarn;

b. an elongated collapsible tube having substantially the length of saidyarn element and being connected thereto along substantially the entirelen h; v c. a c dnnector thread attached to the upper inner wall of saidinner capsule and attached to said element consisting of a yarn untilsaid capsule reaches the duodenum where it is adapted for release uponmanual withdrawal of said elongated element.

1. A carrier system for delivery of an end of an elongated member to theupper gastrointestinal tract comprising: a. an outer gelatinpharmaceutical capsule dissolvable in the upper gastrointestinal tractfrom the normal presence of moisture and warmth and having an opening inone end thereof; b. an inner capsule enclosed by said outer capsulehaving an open end bstantially coaxially aligned with the opening ofsaid outer capsule, and being non-soluble in said gastrointestinal tractand completely contained within said outer capsule, and having inwardlydeflectable walls collapsible in the absence of said outer capsule byperistaltic action present in the upper gastrointestinal tract forlightly grasping the element of paragraph (d) below between the edges ofthe walls: c. a weight, non-dissolvable in the upper gastrointestinaltract, carried in the bottom portion of said inner capsule and providingstructural support to the walls of the inner capsule at said bottomportion so that said inner capsule is of sufficient bulk to be readilyadvanced by peristaltic action through the stomach; d. an elongatedflexible element releasably connected to said inner capsule and having afirst position substantially contained within said inner and outercapsules for playing out of said capsule openings to a second distendedposition within said gastrointestinal tract, said inner capsulecontaining said elongated element which is adapted for remaining aftersaid outer capsule has dissolved and until said inner capsule has movedto the duodenum; and e. said elongated element and said inner capsuleadapted for remaining connected during delivery of the distal end ofsaid element to the duodenum, and said inner capsule adapted for beingreleasable from said element in the duodenum upon manually withdrawingsaid elongated element.
 2. A device as described in claim 1 wherein saidelongated element is a flexible line of yarn.
 3. A device as describedin claim 1 including radiopaque markers attached to the elongatedelement at selected intervals so that the position and course of theline in the gastrointestinal tract may be determined by x-ray.
 4. Adevice as described in claim 1 comprising: a. a first thread connectedto said inner capsule; b. the distal end of said elongated element beingformed with a knot; and c. the free end of said first thread beingconnected to said elongated element by said knot and releasabletherefrom in the duodenum by manual withdrawal of said elongatedelement.
 5. A device as described in claim 1 comprising: a. said innercapsule is made from silicone rubber; and b. a second thread connectedtO the proximal end of said elongated member, having a length adapted toextend from the mouth through the throat.
 6. A device as described inclaim 1 wherein said elongated element is a flexible collapsible tube.7. A device as described in claim 6 comprising: a. a length of yarnconnected to the distal end of said tube and having a knot formed in itsfree end. b. a connector thread attached to the upper inner wall of saidinner capsule and attached to said length of yarn by said knot; and c.said knot adapted for holding said connector thread until said innercapsule reaches the duodenum.
 8. A device as described in claim 1comprising: a. said elongated element consisting of a yarn; b. anelongated collapsible tube having substantially the length of said yarnelement and being connected thereto along substantially the entirelength; c. a connector thread attached to the upper inner wall of saidinner capsule and attached to said element consisting of a yarn untilsaid capsule reaches the duodenum where it is adapted for release uponmanual withdrawal of said elongated element.